CLASS II Drug recall · Reported 24 May 2017 · FDA Enforcement Report

HCG ** MDV 500U/ML INJ, Injection, 500u/mL recalled

Key Pharmacy and Compounding Center is recalling HCG ** MDV 500U/ML INJ, Injection, 500u/mL, distributed nationwide in the US. The recall was initiated on 18 Apr 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 01-20-2017@74, Exp 4/20/2017; t02-01-2017@123, Exp 5/3/2017; t02-03-2017@47, Exp 5/7/2017; t02-07-2017@70, Exp 5/10/2017; t02-13-2017@100, Exp 5/15/2017.
Quantity recalled72 vials

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number
D-0720-2017
FDA event ID
76912
Recalling firm
Key Pharmacy and Compounding Center, Federal Way, WA
Classification
Class II
Status
Terminated
Recall initiated
18 Apr 2017
FDA classified
17 May 2017
Reported
24 May 2017
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

18 Apr 2017Recall initiated by company
17 May 2017Classified by FDA+29 days
24 May 2017Published in enforcement report+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

HCG *10ML* MDV 500U/ML INJ, Injection, 500u/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy

Where it was distributed

Distributed nationwide in U.S.A., Australia and Canada.

Nationwide

Questions about this recall

Why was it recalled?

Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.

Which lots are affected?

Lot # 01-20-2017@74, Exp 4/20/2017; t02-01-2017@123, Exp 5/3/2017; t02-03-2017@47, Exp 5/7/2017; t02-07-2017@70, Exp 5/10/2017; t02-13-2017@100, Exp 5/15/2017.

Where was it sold?

Distributed nationwide in U.S.A., Australia and Canada.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

78 other products · FDA event 76912

This product is part of a recall event; the main page for the event is Procaine HCL ** Sdv Sulfite Free 1% Inj, Injection recalled.

ReportedClassRecallCompanyReasonWhere
CLASS IIProcaine HCL ** Sdv Sulfite Free 1% Inj, Injection recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIQuad Mix 50/30/1/0.2 Mdv (Calif) Mcg/MG/MG/MG/ML Inj recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIAlpha Lipoic Acid Mdv 25MG/ML Inj, Injection, 25mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IISodium Carboxym-cell PF 0.5% Ophth, opthalmic recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIVitamin D3 IN Olive Oil Sdv 100,000U/ML Inj, Injection, 150,000u/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIPGE1/Procaine MDV 20MCG/ML/0.1% INJ, Injection, 20mcg/ml recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIVitamin D3 IN Olive Oil Sdv 100,000U/ML Inj, Injection, 100,000u/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIProcaine HCL SDV 1% INJ, Injection recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIHydroxo-B12 Pbf Mdv (Calif) 10MG/ML Inj, Injection, 10mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IITRI MIX 5.95/17.8572/0.6 MDV MCG/MG/MG/ML INJ, Injection recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS II5-Mthf Mdv (Calif) 5MG/ML Inj, Injection, 5mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIPapaverine/Phent Mdv 30/1MG/ML Inj, Injection, 30mg/1mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS II5-MTHF ** MDV 5MG/ML INJ, Injection, 5mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IITestost Cyp Sesame Oil Mdv 100MG/ML Inj, Injection, 100mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIHydroxo-B12 SDV 10MG/ML INJ, Injection, 10mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IITRI MIX 16.7/4/0.27 MDV MCG/MG/MG/ML INJ, Injection recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS II5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IITRI MIX 5.88/17.65/0.588 MDV MCG/MG/MG/ML INJ, Injection recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IITRI MIX 30/30/1 MDV MCG/MG/MG/ML INJ, Injection, 30mcg/30mg/1mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIPGE1/Procaine MDV 40MCG/ML/0.1% INJ, Injection, 40mcg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IISod Phenylbutyrate Sdv (Calif or Nez-calif) 200MG/ML Inj recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIMethyl-B12 ** MDV 5MG/ML INJ, Injection, 5mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIPyridoxal-5-Phos Mdv 100MG/ML Inj, Injection, 100mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IITestost AQ MDV 50MG/ML INJ, Injection, 50mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIPGE1/PAP 10/30 MDV MCG/MG/ML INJ, Injection, 10mg/30mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIQUAD MIX 1/30/0.5/0.1 MDV MCG/MG/MG/MG/ML INJ, Injection recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IITRI MIX 20/20/1 MDV MCG/MG/MG/ML INJ, Injection, 20mcg/20mg/1mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIHydroxo-B12 Inh PF GV 5MG/ML Soln, Inhalation Solution, 5mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS II5-Mthf Sdv (Calif) 5MG/ML Inj, Injection 5mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIProcaine HCL Mdv (Calif) 1% Inj, Injection recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IITRI MIX 10/30/1 MDV MCG/MG/MG/ML INJ, Injection, 10mcg/30mg/1mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IITRI MIX 10/15/2.5 MDV MCG/MG/MG/ML INJ, Injection recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IITRI MIX 11.8/17.6/0.59 MDV MCG/MG/MG/ML INJ, Injection recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIHydroxo-B12 ** SDV 1MG/ML INJ, Injection, 1mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIHydroxo-B12 PBF MDV 1MG/ML INJ, Injection, 1mg/ml recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IICyanocobalamin MDV 1MG/ML INJ, Injection, 1mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIAtropine Sulfate 0.01% Ophth, Ophthalmic recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIPyridoxal-5-Phos Mdv 50MG/ML Inj, 50mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIVitamin B Complex Sdv NA Inj, Injection, 100mg/2mg/2mg/2mg/100mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IITRI MIX 20/30/1 MDV MCG/MG/MG/ML INJ, Injection, 20mcg/30mg/1mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IITRI MIX 5/30/0.5 MDV MCG/MG/MG/ML INJ, Injection, 5mcg/30mg/0.5mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIProgesterone Sesame Oil Mdv 100MG/ML Inj, Injection, 100mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIFerr Gluc Mdv 60MG/ML Inj, Injection, 60mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIDmso 6.25% Ophth. recalled by Key Pharmacy and CompoundingKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIAtropine Sulfate 0.5% Ophth, Ophthalmic recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIMagnesium SO4 MDV 50% INJ, Injection recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IITRI MIX 10/15/1 MDV MCG/MG/MG/ML INJ, Injection, 10mcg/15mg/1mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIHydroxo-B12 Pbf Mdv (Calif) 1MG/ML Inj, Injection, 1mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIHydroxo-B12 PBF MDV 5MG/ML INJ, 5mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIGSH/NAC INH PV 60/100MG/ML SOLN, Inhalation Solution, 60mg/100mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIGSH/NAC INH PV 150/50MG/ML SOLN, Inhalation Solution, 150mg/50mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IITRI MIX 20/30/2 MDV MCG/MG/MG/ INJ, Injection, 20mcg/30mg/2mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIPGE1 MDV 20MCG/ML INJ, Injection, 20mcg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IITRI MIX 40/30/4 MDV MCG/MG/MG/ML INJ, Injection, 40mcg/30mg/4mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIIron Special Mdv 60/10MG/5MCG/ML Inj, Injection, 60mg/1mg/5mcg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIFolic Acid Sdv 10MG/ML Inj, Injection, 10mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIFerr Gluc/Procaine Mdv 60/10MG/ML Inj, Injection, 60mg/10mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IICHOL/IN/ME(L)/B6 MDV 50/50/25/0.1MG/ML INJ, Injection recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIPapaverine/Phent Mdv 30/0.5MG/ML Inj, Injection, 30/0.5mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIGlutathione Inh *PV* 200MG/ML Soln, Inhalation Solution, 200mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IITRI MIX 20/30/0.5 MDV MCG/MG/MG/ML INJ, Injection recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIProcaine HCL SDV 2% INJ, Injection recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIDmps Acid ** Sdv 50MG/ML Inj, Injection, 50mg/ml recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIFolinic Acid Mdv (Calif) 5MG/ML Inj, Injection, 5mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IITRI MIX 45.45/27.27/0.45 MDV MCG/MG/MG/ML INJ, Injection recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IITRI MIX 40/30/2 MDV MCG/MG/MG/ML INJ, Injection, 40mcg/30mg/2mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIFolinic Acid Mdv Inj, Injection, 10 mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIHydroxo-B12 PBF MDV 10MG/ML INJ, Injection, 10mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IISodium Bicarb Mdv 8.4% (2 Mosmol/ML) Inj, Injection recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIPGE1/CPZ MDV 20MCG/1MG/ML INJ, Injection, 20mcg/1mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIMethyl-B12 Mdv (Calif) 1MG/ML Inj, Injection, 1mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IITRI MIX 13/30/0.8 MDV MCG/MG/MG/ML INJ, Injection recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IITRI MIX 10/30/0.5 ** MDV MCG/MG/MG/ML INJ recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IICo-q-10 Oil Mdv (Calif) 25MG/ML Inj, Injection, 25mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IITRI MIX 6/18/0.6 MDV MCG/MG/MG/ML INJ, Injection, 6mcg/18mg/0.6mg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIPGE1 MDV INJ, Injection, 40mcg/mL recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IIVIT C/GSH 1.25%-1.25% Ophth, Ophthalmic recalledKey Pharmacy and Compounding CenterSterilityNationwide
CLASS IISodium Chloride Inh PF GV 0.9% Soln, Inhalation Solution recalledKey Pharmacy and Compounding CenterSterilityNationwide

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